BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243177 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01688
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S MOTHER REPORTED THAT THE PT EXPERIENCED AN E6 (MECHANICAL ERROR) ON HIS INFUSION DEVICE. THE PT STATED THAT HE ATTEMPTED TO CLEAR THE ERROR BY PERFORMING THE CHANGE CARTRIDGE PROCEDURE. HE STATED THAT THE PISTON ROD RETRACTED BUT WHEN HE PRESSED THE UP OR DOWN BUTTONS TO ADJUST THE PISTON ROD THE INFUSION DEVICE MADE A GRINDING NOISE. HE STATED THAT HE IS UNSURE IF INSULIN HAS EVER BEEN SPILLED INTO THE CARTRIDGE COMPARTMENT. HE STATED THAT THE INFUSION DEVICE HAS NOT BEEN DROPPED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP FPA DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR INSULIN INFUSION SET| INSULIN